Type of Service Provider	Consulting Firm
Type of Industry	Pharmaceutical
Type of Service Contract	One-Time
Industry	FOOD, Cosmetic, Packaging, Medical Device

US FDA Registration Services (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED) and veterinary products.

Type of Service Provider	Consulting Firm
Type of Industry	Chemical
Type of Service Contract	Retainer Based

We hold specialty in providing to our customers a broad spectrum of DMF Service. Provided by our professionals for numerous paces, these are in line with the latest market developments. Besides this, their tandem with the needs of our customers has helped us in attaining the credibility and trust of our customers in the best possible manner.

Specifications:

Primary Packaging material is the material which is directly is contact with the Product and the same material holds the product. The main purpose of Primary packaging is to protect the product from any chemical, biological, climatic or any other hazards which will result in product deterioration.

Some examples of Primary Packaging are:

Glass Ampoule, Glass Vial, Plastic Bottles, Dropper Bottles, Rubber Stopper, etc

Why Packaging Material DMF:

US FDA requires NDA / ANDA/ IND must contain details about drug and packaging that are pertinent to the safety, purity and efficacy of the drug. Similarly other regulatory agencies around the world require such information about primary packaging material and excipients used in drugs. Seeking the importance of Primary Packaging Material in Pharmaceutical packaging, manufacturers should file US DMF type III for their Packaging Material or prepare DMF for their packaging product which can be submitted to their clients when required.

PPC Provides the Following Services in regards to Primary Packaging material & excipients:

• DMF Compilation and Preparation as per requirement of Client
• US DMF Type III DMF DMF Submission and Registration for Packaging material.
• US DMF Type IV DMF DMF Submission and Registration for Excipients.
• Quality Audit for Primary Packaging materials Manufacturers
• Review and Annual Updates of DMFs
• Technical Testing of Primary Packaging Material & Excipients